From Concept through Commercialization: Solutions for Breakthrough Technologies
New technologies and treatments in the health care field require cutting-edge solutions to maximize their market potential. The health care innovations team at Akin Gump Strauss Hauer & Feld LLP combines our legal, public policy, scientific and technical experience with the resources of a full-service firm to develop and implement strategies tailored to each client’s objectives. We provide a “one-stop shop” to guide clients through the complex regulatory and policy matters that arise while developing and commercializing the latest innovations in health care. Our experience includes providing strategic advice to a range of organizations, from large companies with broad product portfolios to start-ups bringing their first products to market, and advising venture capital and private equity firms regarding the market potential for emerging technologies.
Akin Gump’s interdisciplinary approach draws on our in-depth and firsthand knowledge of Food and Drug Administration (FDA) regulation, coverage and reimbursement, and public policy issues, supported by the firm’s extensive experience in the areas of intellectual property; corporate governance and transactions; program compliance, including fraud and abuse laws; and cybersecurity, privacy and data protection laws. We combine our skills to help organizations successfully bring their health care innovations to market and lay the foundation for long-term success. From an idea’s inception to commercialization, the comprehensive approach of our innovations team ensures that our clients meet their business objectives.
Our Integrated Team: Experience Matters
For our pharmaceutical, medical device, biotechnology and other health care industry clients, we understand the enormous undertaking of introducing new and existing products to the marketplace. Collectively, our team has decades of government experience, with members having served in prominent roles with the Department of Health and Human Services (HHS), including within the Centers for Medicare and Medicaid Services (CMS), the FDA, and the Center for Consumer Information and Insurance Oversight (CCIIO). Our innovations team has helped many clients successfully commercialize new products by providing strategic advice and engaging with regulatory authorities through all stages of the process.
Navigating the Food and Drug Administration
Our FDA practice entails representation of clients in all FDA-regulated areas, including prescription drugs, biologics, medical devices and new mobile technologies that have potential medical device applications. Our FDA lawyers routinely advise clients on how to position their innovative products and on the optimal regulatory track to achieve their goals. Due to the importance of CMS coverage decisions, we are particularly adept at advising clients of the value of initiating strong CMS advocacy positions concurrent with pursuing FDA approval. By leveraging our multidisciplinary experience, we are uniquely positioned to assist growing companies to navigate the entire range of FDA regulatory and related issues within the confines of a single firm, from product development to postmarket compliance.
Maximizing Market Potential: Coverage and Reimbursement Strategies
Whether a product is an established technology or a new one, successful commercialization depends on adequate Medicare, Medicaid, and private-payer coverage and reimbursement. Our team members have served in senior positions in Congress, CMS, HHS, FDA and the Department of Justice (DOJ). Our experience includes:
- realizing market potential through cutting-edge coding, coverage and reimbursement strategies
- developing comprehensive regulatory approaches for government agencies and private payers
- using payer advisory boards to inform and refine commercialization strategies
- achieving favorable formulary placement
- developing clinical trial strategies to ensure reimbursement and coverage
- building the evidence base through data development initiatives to maximize coverage and reimbursement
- integrating U.S. and global reimbursement and coverage strategies to meet business objectives.
Addressing Health Information Privacy and Security Issues
The health care innovations team also offers a complete range of regulatory and transactional services related to compliance with cybersecurity, privacy and data protection laws, including the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health Act of 2009 (together with their implementing regulations, “HIPAA”), Section 5 of the Federal Trade Commission Act (Section 5), and state laws relevant to health information privacy and cybersecurity. Our team has experience developing and implementing strategies for addressing privacy compliance risks associated with the often complex data flows involved in developing and deploying new health care innovations. We have assisted clients in addressing privacy and data security challenges presented by digital health solutions, including advising on data collection and use strategies, crafting privacy policies and consent forms, assisting with complex contracting issues, and tailoring data breach response plans to accommodate new products and data streams.
In analyzing risk and developing client-oriented strategies, we consider not just the letter of the law, but current government enforcement priorities, compliance trends and the broader policy and economic environment.
Compliance and Program Integrity
As new companies successfully commercialize their products, quality and reputation become critical to their ongoing success, and they become more likely targets for government oversight and enforcement. Companies need a proactive compliance plan and the capability to respond swiftly to government investigations or enforcement actions. The health care innovations team offers a full range of services related to program integrity and compliance with regulatory regimes, such as the False Claims Act and its qui tam (whistleblower) provisions; the Anti-Kickback Statute; the Stark (self-referral) Laws; and the Food, Drug, and Cosmetic Act. Our team helps to develop and implement plans to ensure adherence with program integrity requirements and the fraud and abuse laws; defend clients against fraud investigations and actions initiated by whistleblowers or the government; and respond to program integrity initiatives.
Akin Gump is nationally recognized for its experience in legislative and public policy matters affecting the drug, biologics and medical device sectors. We counsel clients on a broad range of legal and policy issues arising under federal statutes, rules and regulatory provisions. We also have an active federal funding practice that has succeeded in securing funding for our clients for numerous health care initiatives. Many members of our health practice have served in high-ranking positions in administrative agencies and on congressional committees, helping us provide clients with a deeper understanding of health care regulatory systems and the development of health care policies on Capitol Hill.
Our team is adept at developing allies for products and services, including outreach to patient communities, providers and other key stakeholders. We are also skilled at building markets for new products through legislative and policy developments.
Protection of Intellectual Property (IP)
With the passage of the America Invents Act, numerous agency attacks on issued patents and applications are now permitted. Our agency relationships and experience afford our clients unprecedented mechanisms to attach or defend issued patents and applications. In addition, our patent litigation and enforcement team comprises technically trained patent attorneys and seasoned trial attorneys who implement effective strategies to meet clients’ business objectives.
We have an exceptionally strong team that handles patent infringement litigation, primarily in the pharmaceutical, biotech and medical device sectors. What distinguishes us from other patent litigators is that our team comprises lawyers who are scientists by training; experienced, registered patent attorneys; and accomplished trial lawyers.
Our trademark and copyright practice is based on the principle that trademarks and copyrights should be value creators in our clients’ businesses. We handle all copyright-related matters ranging from registration, first-sale and work-for-hire issues to litigation in federal court. We also have an extensive litigation practice for the enforcement of trademark rights, including trade dress, and for termination of unfair competition in both traditional and e-commerce marketplaces.
Akin Gump also helps protect and defend our clients from legal liability, reputational damage and financial loss resulting from counterfeit, substandard or unsafe goods, as well as from piracy, infringement and misappropriation of IP rights. We employ a broad, holistic strategy to combat counterfeit, substandard, unsafe or pirated goods. We approach brand protection from three angles:
- careful assessment of a company’s exposure in order to develop an anticounterfeiting and brand protection program that addresses the operational and legal aspects of the problem
- vigorous pursuit of increasingly nimble and creative perpetrators by using the many legal tools available
- active participation in the policy process to ensure that proper legislation is enacted and enforced.
Corporate Governance and Transactions
Akin Gump provides substantial general corporate and transactional services to its health industry clients. Our health industry regulatory lawyers, including our privacy and cybersecurity team, work closely with our corporate lawyers, antitrust professionals and tax practitioners, and we are adept at assembling and coordinating teams that work on an array of transactions, corporate finance and securities matters, and corporate governance issues.